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FDA Grants Emergency Use Authorization for 1drop's Coronavirus Test

NEW YORK — The US Food and Drug Administration on Monday granted Emergency Use Authorization for 1drop's PCR-based SARS-CoV-2 test.

The 1copy COVID-19 qPCR Multi Kit is designed to detect the E and RdRp genes of SARS-CoV-2 in nasopharyngeal, oropharyngeal, anterior nasal, and midturbinate nasal swab specimens, as well as nasopharyngeal wash/aspirates and nasal aspirate specimens. According to South Korea-based 1drop, the test provides results within two hours.

Last month, 1drop's test received an authorization for importation and sale in Canada, where it is exclusively distributed by Luminarie Canada.